Home-Based Brain Stimulation for Motoric Cognitive Risk Syndrome

Part of paid clinical trials in Roslindale, Massachusetts.

Sponsor
Hebrew SeniorLife
Study ID
NCT06821568
Status
Recruiting
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Conditions

  • Alzheimer Disease and Related Dementias
  • Cognition
  • Mobility Disability

Eligibility Criteria

Sex
ALL
Age
65 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Personalized Transcranial Direct Current Stimulation (tDCS) — OTHER
    Home-based transcranial direct current stimulation (tDCS) tailored to target the left dlPFC.
  • Active-Sham — OTHER
    Stimulation administered in very low-level currents (0.5 mA total) designed to not significantly influence cortical tissue, but still mimic the cutaneous sensations induced by tDCS.

Study Details

The objective of this study is to determine the effects of a 6-month, home-based personalized transcranial direct current stimulation (tDCS) intervention targeting the left dorsolateral prefrontal cortex on cognitive function, dual task standing and walking, and other metrics of mobility in older adults with motoric cognitive risk syndrome (MCR).

Key Dates

Start date
Sep 2, 2025
Status verified
Sep 2025
Primary completion
Mar 31, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Personalized Transcranial Direct Current Stimulation (tDCS)
    After an initial open-label 2-week home-based transcranial direct current stimulation (tDCS) intervention, participants will receive 5 weekly home-based tDCS sessions for 6 months. Baseline MRIs will enable personalization of tDCS via current flow modeling for optimization to each participant with the goal of generating an average electric field of 0.25 V/m within their identified left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
  • Active Comparator: Combination Arm; Sham Plus Personalized Transcranial Direct Current Stimulation (tDCS)
    After an initial open-label 2-week home-based transcranial direct current stimulation (tDCS) intervention, participants will receive a combination arm of five weekly tDCS sessions for 3 months before or after five weekly sessions of sham for 3 months. The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS. Participants in the combination arm will not know whether they are receiving tDCS or sham during the first or second 3-month period.

Primary Outcome Measure

Dual task cost to gait speed [ Time Frame: Pre-randomization baseline; within three days of completing the initial open-label tDCS intervention; Month 3, Month 6; Month 9. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hebrew Rehabilitation CenterRoslindaleMassachusetts02131
Katie Baldyga, BA
[email protected]
617-971-5380
Juhi Salecha, MS
[email protected]
617-971-5398
Brad Manor, PhD (PRINCIPAL_INVESTIGATOR)

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Hebrew Rehabilitation Center· Roslindale, MA

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